Regulatory news
Germany (BfArM): New Procedure for Exemption from Additional Manufacturer Discount
Germany's Federal Institute for Drugs and Medical Devices (BfArM) has published details of the application procedure for the new exemption from the additional manufacturer discount ("ergänzender Herstellerabschlag") under §130a(1c) SGB V.
The provision applies to medicinal products containing new active substances that are first placed on the German market on or after 1 January 2027.
This allows pharmaceutical companies to apply for an exemption from the supplementary manufacturer's discount (ergänzender Herstellerabschlag).
Core Exemption Rule:
Pharmaceutical companies can request a full exemption from the additional 8.5% manufacturer rebate (applicable starting January 1, 2027, under § 130a para 1b SGB V) for innovative therapies.
- Target Products: Only medicinal products containing new active ingredients (neue Wirkstoffe) that are placed on the German market for the first time on or after January 1, 2027.
- The 5% Clinical Trial Threshold: To successfully quality for the exemption, the pharmaceutical entrepreneur must demonstrate that at least 5 percent of the clinical trial participants involved in the drug's clinical development program were enrolled in trial sites located in Germany.
The application and verification process are managed by Germany's federal authorities:
- The application must be formally submitted to the Federal Institute for Drugs and Medical Devices (BfArM). The Paul-Ehrlich-Institut (PEI) collaborates on the process for relevant biological/vaccine products.
- Applications are processed digitally via an electronic submission portal hosted on PharmNet.Bund.
- Required Documentation: Companies must submit precise technical data and structured proof identifying the total global trial population versus the exact cohort tested in Germany to satisfy the 5% threshold.
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Applications can be submitted no earlier than the marketing authorization application for the medicinal product and must be filed via an electronic submission portal.
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BfArM has issued detailed procedural guidance and FAQs to support applicants.
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The FAQs clarify the definition of a“new active substance”, linking eligibility to the first authorization of the active substance and the existence of applicable regulatory exclusivity periods (e.g., data exclusivity or orphan market exclusivity).
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BfArM also provides clarification on which clinical studies may be considered when assessing eligibility, including studies conducted or commissioned by the pharmaceutical company.
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